Rectal AdenocarcinomaAWWDNCT06631443
Asian Watch-and-Wait Database (AWWD)
An observational study of Rectal Adenocarcinoma and Rectal Cancer, run by Tata Memorial Centre at 1 site in India.
Trial summary
The standard treatment approach of localized rectal adenocarcinoma involves neoadjuvant radiotherapy and chemotherapy followed by assessment for surgery and optional adjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Adenocarcinoma, Rectal Cancer
- How many people
- 337 participants
- Where
- 1 siteIndia
- Study dates
- 22 Oct 2024to Oct 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with localized rectal adenocarcinoma being treated at hospitals or institutes
Who may be able to join
- Histologically confirmed diagnosis of adenocarcinoma of the rectum
- Age ≥18 years
- Clinical stage T1-T4, N0-N2, M0 at diagnosis
- ECOG Performance status 0-1
- Neoadjuvant treatment with either short course or long course radiation therapy and / or chemotherapy
- Complete or near complete clinical response after neoadjuvant therapy
- Patients willing to be on watch-and-wait strategy.
- The distance from anal verge of tumor up to 10 cm (Mid and low rectal tumors)
Who cannot join
- Recurrent rectal cancer
- Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study.
- Not willing to consent for the study or to follow up routinely
- Patients who cannot read or understand the language of QoL
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dr. Shivakumar Gudi, MBBS, MD (Radiation Oncology) contact
India1 site, 1 recruiting
- Recruiting
Tata Memorial Centre
Mumbai, Maharashtra, 400012
Dr Shivakumar Gudi, MBBS, MD (Radiation Oncology), + 91 022 24177000 ext. 6863, shivakumargudi@gmail.com
About this study
Official title: Evaluation of Clinical Outcome in Asian Patients with Localized Rectal Adenocarcinoma Managed with Watch-and-wait Approach by Developing a Multinational Collaborative Database.
The standard treatment approach of localized rectal adenocarcinoma involves neoadjuvant radiotherapy and chemotherapy followed by assessment for surgery and optional adjuvant chemotherapy. However, such patients who achieve complete of near complete clinical response after neoadjuvant therapy are increasingly being managed with the 'Watch-and-Wait strategy' in the recent years. Although safety of such policy has been established, the patient population in the published studies are not represented well by Asian population. Moreover, the data about safety of such policy in the setting of modern neoadjuvant strategies is limited. The Principle Investigator propose a multinational collaborative prospective database study in Asia to systematically collect data on patients being managed with such a strategy. The target population is patients with localized rectal adenocarcinoma achieving near complete or complete response being managed by the Watch-and-Wait strategy. The primary end point being local regrowth and other survival and quality of life end points will be evaluated as well. A secure multinational database will be generated over 5 years with an estimated expected minimal sample size of 337 patients over 5 years across 7-10 Asian institutes to precisely evaluate the required endpoints. Ethical and legal requirements will be met at each participating institute.
Read the detailed description
Neoadjuvant radiation and chemotherapy followed by total mesorectal excision (TME) remains a standard approach in most of the centres globally. Although the oncological outcomes have improved significantly with this multimodality approach over the last few decades, this approach adversely affects quality of life and functional outcomes especially for those needing permanent colostomy. More recently, patients achieving complete or near complete response are increasingly being managed by the 'Watch-and-Wait' approach where in, patients are followed using an intense follow up protocol after radiation and chemotherapy and avoid or delay surgery(1)(2)(3)(4)(5). However, this approach has not been widely adopted worldwide and there is limited data in the published medical literature. While the randomized trials in this setting does not appear to be feasible for obvious ethical reasons, robust data collected both retrospectively and prospectively can provide insights into this approach and help us refine the Watch-and-Wait approach in our routine clinics and in optimizing patient selection and surveillance strategies. Such an attempt was done by developing a multinational database from the Netherlands, Brazil, Portugal, and the UK(6). This data base consisted of more than a thousand patients and several important clinical questions were answered using this data(7)(8). However, this database largely consisted of patients treated using long course chemoradiation which was considered a standard treatment previously at that time. Moreover, there was no representation from Asian countries in this database. Currently, with the recent publications from the large, randomized trials like RAPIDO, UNICANCER PRODIGE 23, OPRA, more and more patients with locally advanced non-metastatic rectal adenocarcinoma are managed with a total neoadjuvant therapy approach(9)(10)(11). Radiotherapy dose escalation using brachytherapy has also gained interest with recent publication of results from the OPERA trial(12). Hence, with these developments, management practice of locally advanced rectal adenocarcinomas has become heterogeneous across institutions globally. These patients are being treated with more aggressive neoadjuvant therapies including total neoadjuvant therapy (TNT) approach. Many of these regimens involve multiagent neoadjuvant chemotherapy in addition to chemoradiation or short course hypofractionated radiotherapy leading increased response rates. The knowledge about the risks and benefits of watch-and-wait strategy after newer neoadjuvant strategies is somewhat limited. It is not entirely known whether the watch-and-wait approach can be applied safely to these patients who achieve clinical complete response after more aggressive neoadjuvant therapy regimens. Also, the data on Asian patients managed with such a strategy is scarce in the literature. Not only the inherent biological and genetic factors associated with rectal adenocarcinoma in Asian patients may be different but also the compliance and feasibility of intense surveillance protocol can be challenging in some of the Asian countries. Considering all these, the principle investigator intend to develop a comprehensive and secure database exclusively from Asian countries and to collect meaningful data systematically to answer important clinical questions on watch-and-wait strategy in Asian patients. This effort is likely to strengthen available evidence on this subject and generate evidence based on data exclusively from Asian patients. Collective efforts from participating nations can facilitate mutual learning and help in safe adoption of the watch-and-wait strategy in a greater number of centres across Asia. This collaborative study among Asian countries may potentially pave the way for future studies of similar kind.
- Conditions
- Rectal Adenocarcinoma, Rectal Cancer
- Keywords
- AWWD, Asian wait and watch database, Multicentric, Database, Registry, Watch and Wait, Non Operative management
- Medical subject headings
- Rectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Local regrowth rate
To determine the local regrowth rates at 2 years in Asian patients managed with the watch-and-wait strategy after neoadjuvant therapy in rectal cancer.
Measured: 2 years
Secondary outcomes (11)
Overall Survival Rates
Rates of overall survival at 2 years is measured as a time to event end point from the date of diagnosis to date of death from any cause
Measured: 2 years
Overall Survival Rates
Rates of overall survival at 5 years is measured as a time to event end point from the date of diagnosis to date of death from any cause
Measured: 5 years
Evaluating Disease-Free Survival
Disease free survival at 2 years is measured as a time to event end point from the date of diagnosis to date of relapse or death from any cause
Measured: 2 years
Evaluating Disease-Free Survival
Disease free survival at 5 years is measured as a time to event end point from the date of diagnosis to date of relapse or death from any cause
Measured: 5 years
Colostomy-Free Survival
Colostomy free survival at 2 years is measured as a time to event end point from the date of diagnosis to date of colostomy or date of death from any cause
Measured: 2 years
Colostomy-Free Survival
Colostomy free survival at 5 years is measured as a time to event end point from the date of diagnosis to date of colostomy or date of death from any cause
Measured: 5 years
Assessing Clinical Complete Response
Clinical complete response rates with respect to various neoadjuvant treatment approaches
Measured: 2 years
Assessing Clinical Regrowth Rates
Clinical regrowth rates with respect to various neoadjuvant treatment approaches
Measured: 2 years
Quality of life Assesment (EORTC QOL30)
To determine Quality of life (QOL) of patients managed with Watch-and-wait policy.
Measured: 2 years
Quality of life Assesment (EORTC QOL CR29)
To determine Quality of life (QOL) of patients managed with Watch-and-wait policy.
Measured: 2 years
Patient Compliance
Compliance of these patients to recommended surveillance protocol
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start22 Oct 2024
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Rectal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Tata Memorial CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 337 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Tata Memorial Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shivakumar Gudi, Tata Memorial Centre
- Investigators
- Shivakumar Gudi Dr., MBBS, MD (Radiation Oncology), Principal investigator, Tata Memorial Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631443
- Sponsor's protocol ID
- 4435
- Acronym
- AWWD
- Status last verified
- Sep 2024
- First submitted
- 1 Oct 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gerard JP, Barbet N, Schiappa R, Magne N, Martel I, Mineur L, Deberne M, Zilli T, Dhadda A, Myint AS; ICONE group. Neoadjuvant chemoradiotherapy with radiation dose escalation with contact x-ray brachytherapy boost or external beam radiotherapy boost for organ preservation in early cT2-cT3 rectal adenocarcinoma (OPERA): a phase 3, randomised controlled trial. Lancet Gastroenterol Hepatol. 2023 Apr;8(4):356-367. doi: 10.1016/S2468-1253(22)00392-2. Epub 2023 Feb 16.
PubMed 36801007Garcia-Aguilar J, Patil S, Gollub MJ, Kim JK, Yuval JB, Thompson HM, Verheij FS, Omer DM, Lee M, Dunne RF, Marcet J, Cataldo P, Polite B, Herzig DO, Liska D, Oommen S, Friel CM, Ternent C, Coveler AL, Hunt S, Gregory A, Varma MG, Bello BL, Carmichael JC, Krauss J, Gleisner A, Paty PB, Weiser MR, Nash GM, Pappou E, Guillem JG, Temple L, Wei IH, Widmar M, Lin S, Segal NH, Cercek A, Yaeger R, Smith JJ, Goodman KA, Wu AJ, Saltz LB. Organ Preservation in Patients With Rectal Adenocarcinoma Treated With Total Neoadjuvant Therapy. J Clin Oncol. 2022 Aug 10;40(23):2546-2556. doi: 10.1200/JCO.22.00032. Epub 2022 Apr 28.
PubMed 35483010Conroy T, Bosset JF, Etienne PL, Rio E, Francois E, Mesgouez-Nebout N, Vendrely V, Artignan X, Bouche O, Gargot D, Boige V, Bonichon-Lamichhane N, Louvet C, Morand C, de la Fouchardiere C, Lamfichekh N, Juzyna B, Jouffroy-Zeller C, Rullier E, Marchal F, Gourgou S, Castan F, Borg C; Unicancer Gastrointestinal Group and Partenariat de Recherche en Oncologie Digestive (PRODIGE) Group. Neoadjuvant chemotherapy with FOLFIRINOX and preoperative chemoradiotherapy for patients with locally advanced rectal cancer (UNICANCER-PRODIGE 23): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2021 May;22(5):702-715. doi: 10.1016/S1470-2045(21)00079-6. Epub 2021 Apr 13.
PubMed 33862000Bahadoer RR, Dijkstra EA, van Etten B, Marijnen CAM, Putter H, Kranenbarg EM, Roodvoets AGH, Nagtegaal ID, Beets-Tan RGH, Blomqvist LK, Fokstuen T, Ten Tije AJ, Capdevila J, Hendriks MP, Edhemovic I, Cervantes A, Nilsson PJ, Glimelius B, van de Velde CJH, Hospers GAP; RAPIDO collaborative investigators. Short-course radiotherapy followed by chemotherapy before total mesorectal excision (TME) versus preoperative chemoradiotherapy, TME, and optional adjuvant chemotherapy in locally advanced rectal cancer (RAPIDO): a randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Jan;22(1):29-42. doi: 10.1016/S1470-2045(20)30555-6. Epub 2020 Dec 7.
PubMed 33301740Temmink SJD, Peeters KCMJ, Bahadoer RR, Kranenbarg EM, Roodvoets AGH, Melenhorst J, Burger JWA, Wolthuis A, Renehan AG, Figueiredo NL, Pares O, Martling A, Perez RO, Beets GL, van de Velde CJH, Nilsson PJ; International Watch & Wait Database (IWWD) Consortium. Watch and wait after neoadjuvant treatment in rectal cancer: comparison of outcomes in patients with and without a complete response at first reassessment in the International Watch & Wait Database (IWWD). Br J Surg. 2023 May 16;110(6):676-684. doi: 10.1093/bjs/znad051.
PubMed 36972213Fernandez LM, Sao Juliao GP, Figueiredo NL, Beets GL, van der Valk MJM, Bahadoer RR, Hilling DE, Meershoek-Klein Kranenbarg E, Roodvoets AGH, Renehan AG, van de Velde CJH, Habr-Gama A, Perez RO; International Watch & Wait Database Consortium. Conditional recurrence-free survival of clinical complete responders managed by watch and wait after neoadjuvant chemoradiotherapy for rectal cancer in the International Watch & Wait Database: a retrospective, international, multicentre registry study. Lancet Oncol. 2021 Jan;22(1):43-50. doi: 10.1016/S1470-2045(20)30557-X. Epub 2020 Dec 11.
PubMed 33316218van der Valk MJM, Hilling DE, Bastiaannet E, Meershoek-Klein Kranenbarg E, Beets GL, Figueiredo NL, Habr-Gama A, Perez RO, Renehan AG, van de Velde CJH; IWWD Consortium. Long-term outcomes of clinical complete responders after neoadjuvant treatment for rectal cancer in the International Watch & Wait Database (IWWD): an international multicentre registry study. Lancet. 2018 Jun 23;391(10139):2537-2545. doi: 10.1016/S0140-6736(18)31078-X.
PubMed 29976470Renehan AG, Malcomson L, Emsley R, Gollins S, Maw A, Myint AS, Rooney PS, Susnerwala S, Blower A, Saunders MP, Wilson MS, Scott N, O'Dwyer ST. Watch-and-wait approach versus surgical resection after chemoradiotherapy for patients with rectal cancer (the OnCoRe project): a propensity-score matched cohort analysis. Lancet Oncol. 2016 Feb;17(2):174-183. doi: 10.1016/S1470-2045(15)00467-2. Epub 2015 Dec 17.
PubMed 26705854Appelt AL, Ploen J, Harling H, Jensen FS, Jensen LH, Jorgensen JC, Lindebjerg J, Rafaelsen SR, Jakobsen A. High-dose chemoradiotherapy and watchful waiting for distal rectal cancer: a prospective observational study. Lancet Oncol. 2015 Aug;16(8):919-27. doi: 10.1016/S1470-2045(15)00120-5. Epub 2015 Jul 5.
PubMed 26156652Smith JD, Ruby JA, Goodman KA, Saltz LB, Guillem JG, Weiser MR, Temple LK, Nash GM, Paty PB. Nonoperative management of rectal cancer with complete clinical response after neoadjuvant therapy. Ann Surg. 2012 Dec;256(6):965-72. doi: 10.1097/SLA.0b013e3182759f1c.
PubMed 23154394Maas M, Beets-Tan RG, Lambregts DM, Lammering G, Nelemans PJ, Engelen SM, van Dam RM, Jansen RL, Sosef M, Leijtens JW, Hulsewe KW, Buijsen J, Beets GL. Wait-and-see policy for clinical complete responders after chemoradiation for rectal cancer. J Clin Oncol. 2011 Dec 10;29(35):4633-40. doi: 10.1200/JCO.2011.37.7176. Epub 2011 Nov 7.
PubMed 22067400Habr-Gama A, Perez RO, Nadalin W, Sabbaga J, Ribeiro U Jr, Silva e Sousa AH Jr, Campos FG, Kiss DR, Gama-Rodrigues J. Operative versus nonoperative treatment for stage 0 distal rectal cancer following chemoradiation therapy: long-term results. Ann Surg. 2004 Oct;240(4):711-7; discussion 717-8. doi: 10.1097/01.sla.0000141194.27992.32.
PubMed 15383798
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Outcome in Asian Patients with Localized Rectal Adenocarcinoma Managed with Watch-and-wait Approach by Developing a Multinational Collaborative Database.
- ClinicalTrials.gov ID
- NCT06631443
- Acronym / sponsor ID
- AWWD / 4435
- Conditions
- Rectal Adenocarcinoma, Rectal Cancer
- Keywords
- AWWD, Asian wait and watch database, Multicentric, Database, Registry, Watch and Wait, Non Operative management
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 337 participants (estimated)
- Lead sponsor
- Tata Memorial CentreUniversity, hospital or other
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The standard treatment approach of localized rectal adenocarcinoma involves neoadjuvant radiotherapy and chemotherapy followed by assessment for surgery and optional adjuvant chemotherapy. However, such patients who achieve complete of near complete clinical response after neoadjuvant therapy are increasingly being managed with the 'Watch-and-Wait strategy' in the recent years. Although safety of such policy has been established, the patient population in the published studies are not represented well by Asian population. Moreover, the data about safety of such policy in the setting of modern neoadjuvant strategies is limited. The Principle Investigator propose a multinational collaborative prospective database study in Asia to systematically collect data on patients being managed with such a strategy. The target population is patients with localized rectal adenocarcinoma achieving near complete or complete response being managed by the Watch-and-Wait strategy. The primary end point being local regrowth and other survival and quality of life end points will be evaluated as well. A secure multinational database will be generated over 5 years with an estimated expected minimal sample size of 337 patients over 5 years across 7-10 Asian institutes to precisely evaluate the required endpoints. Ethical and legal requirements will be met at each participating institute.
Detailed description
Neoadjuvant radiation and chemotherapy followed by total mesorectal excision (TME) remains a standard approach in most of the centres globally. Although the oncological outcomes have improved significantly with this multimodality approach over the last few decades, this approach adversely affects quality of life and functional outcomes especially for those needing permanent colostomy. More recently, patients achieving complete or near complete response are increasingly being managed by the 'Watch-and-Wait' approach where in, patients are followed using an intense follow up protocol after radiation and chemotherapy and avoid or delay surgery(1)(2)(3)(4)(5). However, this approach has not been widely adopted worldwide and there is limited data in the published medical literature. While the randomized trials in this setting does not appear to be feasible for obvious ethical reasons, robust data collected both retrospectively and prospectively can provide insights into this approach and help us refine the Watch-and-Wait approach in our routine clinics and in optimizing patient selection and surveillance strategies. Such an attempt was done by developing a multinational database from the Netherlands, Brazil, Portugal, and the UK(6). This data base consisted of more than a thousand patients and several important clinical questions were answered using this data(7)(8). However, this database largely consisted of patients treated using long course chemoradiation which was considered a standard treatment previously at that time. Moreover, there was no representation from Asian countries in this database. Currently, with the recent publications from the large, randomized trials like RAPIDO, UNICANCER PRODIGE 23, OPRA, more and more patients with locally advanced non-metastatic rectal adenocarcinoma are managed with a total neoadjuvant therapy approach(9)(10)(11). Radiotherapy dose escalation using brachytherapy has also gained interest with recent publication of results from the OPERA trial(12). Hence, with these developments, management practice of locally advanced rectal adenocarcinomas has become heterogeneous across institutions globally. These patients are being treated with more aggressive neoadjuvant therapies including total neoadjuvant therapy (TNT) approach. Many of these regimens involve multiagent neoadjuvant chemotherapy in addition to chemoradiation or short course hypofractionated radiotherapy leading increased response rates. The knowledge about the risks and benefits of watch-and-wait strategy after newer neoadjuvant strategies is somewhat limited. It is not entirely known whether the watch-and-wait approach can be applied safely to these patients who achieve clinical complete response after more aggressive neoadjuvant therapy regimens. Also, the data on Asian patients managed with such a strategy is scarce in the literature. Not only the inherent biological and genetic factors associated with rectal adenocarcinoma in Asian patients may be different but also the compliance and feasibility of intense surveillance protocol can be challenging in some of the Asian countries. Considering all these, the principle investigator intend to develop a comprehensive and secure database exclusively from Asian countries and to collect meaningful data systematically to answer important clinical questions on watch-and-wait strategy in Asian patients. This effort is likely to strengthen available evidence on this subject and generate evidence based on data exclusively from Asian patients. Collective efforts from participating nations can facilitate mutual learning and help in safe adoption of the watch-and-wait strategy in a greater number of centres across Asia. This collaborative study among Asian countries may potentially pave the way for future studies of similar kind.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with localized rectal adenocarcinoma being treated at hospitals or institutes
Key inclusion criteria (8 listed)
- Histologically confirmed diagnosis of adenocarcinoma of the rectum
- Age ≥18 years
- Clinical stage T1-T4, N0-N2, M0 at diagnosis
- ECOG Performance status 0-1
- Neoadjuvant treatment with either short course or long course radiation therapy and / or chemotherapy
Key exclusion criteria (4 listed)
- Recurrent rectal cancer
- Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study.
- Not willing to consent for the study or to follow up routinely
- Patients who cannot read or understand the language of QoL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Local regrowth rate
Time frame: 2 years
To determine the local regrowth rates at 2 years in Asian patients managed with the watch-and-wait strategy after neoadjuvant therapy in rectal cancer.
11 secondary outcomes
Overall Survival Rates
Time frame: 2 years
Overall Survival Rates
Time frame: 5 years
Evaluating Disease-Free Survival
Time frame: 2 years
Evaluating Disease-Free Survival
Time frame: 5 years
Colostomy-Free Survival
Time frame: 2 years
Colostomy-Free Survival
Time frame: 5 years
Assessing Clinical Complete Response
Time frame: 2 years
Assessing Clinical Regrowth Rates
Time frame: 2 years
Quality of life Assesment (EORTC QOL30)
Time frame: 2 years
Quality of life Assesment (EORTC QOL CR29)
Time frame: 2 years
Patient Compliance
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Background: PubMed 36801007Gerard JP, Barbet N, Schiappa R, Magne N, Martel I, Mineur L, Deberne M, Zilli T, Dhadda A, Myint AS; ICONE group. Neoadjuvant chemoradiotherapy with radiation dose escalation with contact x-ray brachytherapy boost or external beam radiotherapy boost for organ preservation in early cT2-cT3 rectal adenocarcinoma (OPERA): a phase 3, randomised controlled trial. Lancet Gastroenterol Hepatol. 2023 Apr;8(4):356-367. doi: 10.1016/S2468-1253(22)00392-2. Epub 2023 Feb 16.
- Background: PubMed 35483010Garcia-Aguilar J, Patil S, Gollub MJ, Kim JK, Yuval JB, Thompson HM, Verheij FS, Omer DM, Lee M, Dunne RF, Marcet J, Cataldo P, Polite B, Herzig DO, Liska D, Oommen S, Friel CM, Ternent C, Coveler AL, Hunt S, Gregory A, Varma MG, Bello BL, Carmichael JC, Krauss J, Gleisner A, Paty PB, Weiser MR, Nash GM, Pappou E, Guillem JG, Temple L, Wei IH, Widmar M, Lin S, Segal NH, Cercek A, Yaeger R, Smith JJ, Goodman KA, Wu AJ, Saltz LB. Organ Preservation in Patients With Rectal Adenocarcinoma Treated With Total Neoadjuvant Therapy. J Clin Oncol. 2022 Aug 10;40(23):2546-2556. doi: 10.1200/JCO.22.00032. Epub 2022 Apr 28.
- Background: PubMed 33862000Conroy T, Bosset JF, Etienne PL, Rio E, Francois E, Mesgouez-Nebout N, Vendrely V, Artignan X, Bouche O, Gargot D, Boige V, Bonichon-Lamichhane N, Louvet C, Morand C, de la Fouchardiere C, Lamfichekh N, Juzyna B, Jouffroy-Zeller C, Rullier E, Marchal F, Gourgou S, Castan F, Borg C; Unicancer Gastrointestinal Group and Partenariat de Recherche en Oncologie Digestive (PRODIGE) Group. Neoadjuvant chemotherapy with FOLFIRINOX and preoperative chemoradiotherapy for patients with locally advanced rectal cancer (UNICANCER-PRODIGE 23): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2021 May;22(5):702-715. doi: 10.1016/S1470-2045(21)00079-6. Epub 2021 Apr 13.
- Background: PubMed 33301740Bahadoer RR, Dijkstra EA, van Etten B, Marijnen CAM, Putter H, Kranenbarg EM, Roodvoets AGH, Nagtegaal ID, Beets-Tan RGH, Blomqvist LK, Fokstuen T, Ten Tije AJ, Capdevila J, Hendriks MP, Edhemovic I, Cervantes A, Nilsson PJ, Glimelius B, van de Velde CJH, Hospers GAP; RAPIDO collaborative investigators. Short-course radiotherapy followed by chemotherapy before total mesorectal excision (TME) versus preoperative chemoradiotherapy, TME, and optional adjuvant chemotherapy in locally advanced rectal cancer (RAPIDO): a randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Jan;22(1):29-42. doi: 10.1016/S1470-2045(20)30555-6. Epub 2020 Dec 7.
- Background: PubMed 36972213Temmink SJD, Peeters KCMJ, Bahadoer RR, Kranenbarg EM, Roodvoets AGH, Melenhorst J, Burger JWA, Wolthuis A, Renehan AG, Figueiredo NL, Pares O, Martling A, Perez RO, Beets GL, van de Velde CJH, Nilsson PJ; International Watch & Wait Database (IWWD) Consortium. Watch and wait after neoadjuvant treatment in rectal cancer: comparison of outcomes in patients with and without a complete response at first reassessment in the International Watch & Wait Database (IWWD). Br J Surg. 2023 May 16;110(6):676-684. doi: 10.1093/bjs/znad051.
- Background: PubMed 33316218Fernandez LM, Sao Juliao GP, Figueiredo NL, Beets GL, van der Valk MJM, Bahadoer RR, Hilling DE, Meershoek-Klein Kranenbarg E, Roodvoets AGH, Renehan AG, van de Velde CJH, Habr-Gama A, Perez RO; International Watch & Wait Database Consortium. Conditional recurrence-free survival of clinical complete responders managed by watch and wait after neoadjuvant chemoradiotherapy for rectal cancer in the International Watch & Wait Database: a retrospective, international, multicentre registry study. Lancet Oncol. 2021 Jan;22(1):43-50. doi: 10.1016/S1470-2045(20)30557-X. Epub 2020 Dec 11.
- Background: PubMed 29976470van der Valk MJM, Hilling DE, Bastiaannet E, Meershoek-Klein Kranenbarg E, Beets GL, Figueiredo NL, Habr-Gama A, Perez RO, Renehan AG, van de Velde CJH; IWWD Consortium. Long-term outcomes of clinical complete responders after neoadjuvant treatment for rectal cancer in the International Watch & Wait Database (IWWD): an international multicentre registry study. Lancet. 2018 Jun 23;391(10139):2537-2545. doi: 10.1016/S0140-6736(18)31078-X.
- Background: PubMed 26705854Renehan AG, Malcomson L, Emsley R, Gollins S, Maw A, Myint AS, Rooney PS, Susnerwala S, Blower A, Saunders MP, Wilson MS, Scott N, O'Dwyer ST. Watch-and-wait approach versus surgical resection after chemoradiotherapy for patients with rectal cancer (the OnCoRe project): a propensity-score matched cohort analysis. Lancet Oncol. 2016 Feb;17(2):174-183. doi: 10.1016/S1470-2045(15)00467-2. Epub 2015 Dec 17.
- Background: PubMed 26156652Appelt AL, Ploen J, Harling H, Jensen FS, Jensen LH, Jorgensen JC, Lindebjerg J, Rafaelsen SR, Jakobsen A. High-dose chemoradiotherapy and watchful waiting for distal rectal cancer: a prospective observational study. Lancet Oncol. 2015 Aug;16(8):919-27. doi: 10.1016/S1470-2045(15)00120-5. Epub 2015 Jul 5.
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- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Shivakumar Gudi, MBBS, MD (Radiation Oncology) contact
Shivakumar Gudi Dr., MBBS, MD (Radiation Oncology) principal investigator
Tata Memorial Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Adenocarcinoma and Rectal Cancer, run by Tata Memorial Centre at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Shivakumar Gudi, MBBS, MD (Radiation Oncology) (2224177000 ext. 6863, shivakumargudi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local regrowth rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06631443, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.