India Co-enrolment

Aspirin is being given following (or alongside) standard therapy, rather than replacing any part of current treatment. By including individuals who have already taken part in other treatment trials, we will be able to assess how well aspirin works when given in addition to both current and potentially future standard treatments.

Individuals who are participating in the trials below may also enter the Add-Aspirin trial (providing they are otherwise eligible). If you would like to register an individual who has taken part in another trial, which is not listed here, please contact your designated JSS contact in the first instance.

More information about the appropriate timing of Add-Aspirin registration relative to other treatments is available in the section below (Timing of trial entry within each cohort).

Please remember to complete the Co-enrolment Form (16) on the CACTUS database for any patients who register in Add-Aspirin and are co-enrolled in one of the below trials, unless indicated otherwise (e.g. because it is an observational/sample collection/non-interventional study).

Randomized Controlled Trial Evaluating the Role of Exercise in Women Undergoing Treatment for Breast Cancer (EXERCISE)

A Phase III double blind randomised placebo controlled study of Trastuzumab as short duration preoperative therapy in patients with HER2-neu positive operable Breast Cancer (PERIOP-TRASTUZUMAB)

A randomised controlled study to evaluate the role of Hydroxy Progesterone in prevention of chemotherapy induced neurotoxicity in women with Breast Cancer (TAXANE TOXICITY)

Randomized controlled trial to assess blockade of voltage gated sodium channels during surgery in operable breast cancer (VGSC)

Post-Mastectomy Radiation Therapy in High Risk, Node Negative women with Early Breast Cancer (PMRT-NNBC)

Comparative study of targeted sentinel node biopsy vs. axillary sampling in clinically node negative Breast Cancer after neo -adjuvant chemotherapy (SNB)

To assess the cosmetic outcome in patients undergoing Breast Conservation Surgery(BCS) with or without deep suture approximation of the primary surgical cavity (COSMESIS)

A Phase III Randomized Controlled study of Inj. Proluton (Hydroxyprogesterone caproate) as single dose preoperative therapy in patients with high risk operable breast cancer (PROLUTON)

ARIA-BR Study (CTRI/2017/01/007745)

NAVYA Study (CTRI/2017/11/10480)

Scalp cooling study (CTRI/2017/02/007896) - Co-enrolment eCRF NOT required 

ComPrel  - Compression garment vs Usual care (Control) (CTRI/2017/12/010762)

Post-NACT BCT - Breast conservation surgery vs Modified radical mastectomy (control) (CTRI/2018/07/014767)

Axillary Staging Study - Single arm: Additional axillary staging investigations (REF/2015/07/009488) - Co-enrolment eCRF NOT required

HYPORT - HYPOfractioned Radiation Therapy camparing a standard radiotherapy schedule (over three weeks) with a novel one week schedule in Adjuvant breast cancer: An open label randomised controlled study (CTRI/2018/12/016816) 

IMN Study: Feasibility and implications of thoracoscopic dissection of internal mammary nodes in central and inner quadrant breast cancer

FAFP study: Cancer directed treatment related fertility questionnaire (CTRI/2017/12/010777) - Co-enrolment eCRF NOT required

Hypoxia Study: A Prospective evaluation of the peri-operative Hypoxia in breast cancer - Co-enrolment eCRF NOT required

CONSEQuenCE study: CONcurrent versus SEQuential Chemo-Endocrine Therapy in ER positive and HER 2 Negative non-metastatic breast cancer (CTRI/2018/09/015643)

OFA Study: Prospective randomized study to assess the feasibility of performing opioid free anesthesia with ketamine for elective modified radical mastectomy (CTRI/2020/10/028342)

OMEC: A randomized, open label, parallel-group, phase 3 study to investigate the efficacy and tolerability of palonosetron, dexamethasone, aprepitant plus Olanzapine versus palonosetron, dexamethasone and aprepitant alone in patients receiving high moderately emetogenic chemotherapeutic (MEC) regimens (OMEC study)

Rosuvastatin rectal study: Role of lipid lowering drug in the treatment of rectal cancers /
A randomized phase 2/3 trial of Rosuvastatin with neo-adjuvant chemo-radiation in patients with rectal cancer (CTRI/2018/11/016459)

Survivorship programme for colorectal cancer patients - a randomized study (Tata Memorial Hospital) - Please complete Co-Enrolment eCRF if patient is registered to Add-Aspirin before OR after enrolment to the survivorship programme
 

3 Field radical esoophagectomy vs 2 filed esophagectomy –a prospective randomized controlled trial (2F vs 3F)

CREST: Study to evaluate the efficacy and safety of chemotherapy & Radiation therapy vs observation following
surgery in patients with esophageal cancer.
Please note: Patients should commence the Add-Aspirin run-in period after 6 weeks of CRT, and up to 14 weeks after the last fraction.

ERAS: A pilot study to assess the feasibility and outcomes of implementation of an Enhanced Recovery After Surgery (ERAS) protocol in patients undergoing subtotal gastrectomy for gastric cancer

Hurria score (CTRI/2016/10/007357) - Co-enrolment eCRF NOT required

NACT - 5-Fluorouracil (5-FU) with platinum OR Paclitaxel with platinum for neoadjuvant therapy in cancers of the oesophagus

OMEC: A randomized, open label, parallel-group, phase 3 study to investigate the efficacy and tolerability of palonosetron, dexamethasone, aprepitant plus Olanzapine versus palonosetron, dexamethasone and aprepitant alone in patients receiving high moderately emetogenic chemotherapeutic (MEC) regimens (OMEC study) 

Phase II randomised trial comparing neoadjuvant chemotherapy and neoadjuvant chemoradiotherapy for loco regionally advanced oesophageal cancer (NACT vs NACTRT)

Phase III randomized controlled trial comparing D2 vs. D3 lymphadenectomy on outcomes of non-metastatic resectable but locally advanced gastric cancer following neo-adjuvant (perioperative) chemotherapy (ELIANCE)

Contact Details

If you are an individual who is interested in taking part in Add-Aspirin, please talk to your doctor who will be able to consider whether you are suitable for the trial.

For healthcare professionals

Please log into the members area for Add-Aspirin contact details.

Register Interest

For healthcare professionals

If your centre would like to recruit participants to Add-Aspirin, contact us:
mrcctu.add-aspirin@ucl.ac.uk

Register a participant

From Monday 16th March 2020, to RANDOMISE a participant in the UK please call +44 (0)20 7670 4925, rather than the usual randomisation line.

To RANDOMISE a participant from Republic of Ireland or India only, please use the 'Register a participant' link above to randomise online. Please make sure to press 'Randomise' once logged in to the server.

Unblind a participant in the UK

Unblind a participant in the RoI

Unblind a participant in India