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Rectal CancerPhase 2EXPLORENCT03038256

Effect of Concurrent Capecitabine-based Long-term Radiotherapy Followed by XELOX Plus TME in Patients With High Risk Rectal Cancer: a Multi-centers, Randomized Controlled, Open-Label Trial

A Phase 2 study testing concurrent capecitabine-based long-term radiotherapy followed by 4 cycles XELOX and a delayed TME and concurrent capecitabine-based long-term radiotherapy followed by a Regular TME and 6 Cycles XELOX in people with Rectal Cancer and Pathological Complete Response, run by Peking University People's Hospital at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study was to evaluate the effect of concurrent capecitabine-based long-term radiotherapy followed by 4 cycles XELOX pre- a delayed TME compared with 6 cycles XELOX post- a Regular Timing TME in patients with high-risk rectal cancer defined by MRI. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
concurrent capecitabine-based long-term radiotherapy followed by 4 cycles XELOX and a delayed TME and concurrent capecitabine-based long-term radiotherapy followed by a Regular TME and 6 Cycles XELOX
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
244 participants
Where
2 sitesChina
Study dates
31 Jan 2018to 1 Jun 2025
Phase
Phase 2
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age of 18-75 years;
  • Histologically confirmed adenocarcinoma;
  • The rectal adenocarcinoma 0-12cm from the anal margin on Magnetic resonance imaging (MRI) and/or rigid sigmoidoscopy;
  • High risk of rectal cancer defined by high-resolution MRI: tumor invasion 5mm beyond the muscularis propria, or extramural vascular invasion, or circumferential resection margin unsafe, or the lower rectal cancer invades intersphincteric space, or rectal cancer invades the adjacent structures.
  • Eastern Collaborative Oncology Group performance status score of 0 or 2
  • Able and willing to give informed consent to participate.

Who cannot join

  • Received preoperative chemoradiotherapy for rectal cancer before the recruitment of this study;
  • Have metastatic disease (including non-regional lymph nodes metastases or resectable liver metastases);
  • Other malignancies, non-adenocarcinoma rectal malignancies or rectal malignancies on the basis of inflammatory bowel disease;
  • Emergency surgery due to bowel obstruction, perforation, bleeding, etc.;
  • Abnormality of capecitabine absorption due to gastrointestinal disease e.g. short bowel syndrome, inflammation bowel disease, et al.;
  • Unresectable concurrent intestinal lesions;
Show all 15Show fewer
  • Concurrent severe infection；
  • Cardiac Disease：uncontrolled or symptomatic cardiac angina，or uncontrolled arrhythmias and hypertension, or severe congestive heart failure grade II or more based on New York Heart Association (NYHA); myocardial infarction within the past 12 months
  • Peripheral neuropathy more than grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 3·0)
  • Bone marrow, liver and kidney function are abnormal e.g., white blood cell ≤ 1.5 × 109 / L; platelet ≤ 100 × 109 / L; Haemoglobin ≤ 80 g/L; Bilirubin > 1.5 times the upper limit; aspartate aminotransferase and alanine aminotransferase > 2.5 times the upper limit; creatinine > 1.5 times the upper limit;
  • Pregnant or lactating women;
  • Life prediction less than 3 months, other severe diseases;
  • Contraindication to MRI; e.g. non-MRI compatible hip prosthesis, cardiac pacemaker;
  • Contraindication to standard chemotherapy including drug interactions and glomerular filtration rate <50 mL/min at baseline;
  • Participators who had been recruited by other clinical trial within three months.

Trial locations and contacts

2 sites in 1 country.

Yi Wang, MD, PHD contact

8610-88325813

wangyi@pkuph.edu.cn, jennifer_wy@me.com

Yingjiang Ye, MD, PHD contact

8610-88326608

yeyingjiang@pkuph.edu.cn, yjye101@sina.com

China2 sites, 2 recruiting

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

    Yingjiang Ye, M.D./PhD, +86-13321163682, yeyingjiang@pkuph.edu.cn

    Yancheng Cui, M.D., +86-15201277974, cuiyancheng2007@163.com

    Recruiting

  • Beijing Friendship Hospital

    Beijing, Beijing Municipality

    Zhongtao Zhang, professor

    Not yet recruiting

Other trials in China

About this study

Official title: Effect of Concurrent Capecitabine-based Long-term Radiotherapy Followed by 4 Cycles XELOX Pre- a Delayed TME Compared With 6 Cycles XELOX post-a Regular Timing TME in Patients With High Risk Rectal Cancer: a Multi-centers, Randomized, Open-Label Trial

The purpose of this study was to evaluate the effect of concurrent capecitabine-based long-term radiotherapy followed by 4 cycles XELOX pre- a delayed TME compared with 6 cycles XELOX post- a Regular Timing TME in patients with high-risk rectal cancer defined by MRI.

Read the detailed description

This is the randomized controlled, multi-centers, and open-labeled study. Delivering systemic chemotherapy between concurrent capecitabine-based long-term radiotherapy and total mesorectal excision (TME) surgery would be more effectively improved local control rates and improved metastases-free survival rates. The investigators attempted to investigate the effect on pathological response of delivering 4 cycles XELOX between concurrent capecitabine-based long-term radiotherapy and TME with lengthening the interval from radiation to surgery. In this study, the participants with high risk of deeper infiltration, or extramural vessel invasion, or circumferential resection margin involvement, or surrounding organs and structures invaded et al. were recruited. The participants will be randomized (1:1 ratio) to a control and intervention arm. The participants in the control arm will receive best current practice of concurrent capecitabine-based long-term radiotherapy followed by TME and then a 6 cycles of XELOX as standard adjuvant chemotherapy. The participants in the intervention arm will receive concurrent capecitabine-based long-term radiotherapy followed by 4 cycles XELOX as neoadjuvant chemotherapy pre- a delayed TME.

Being tested
concurrent capecitabine-based long-term radiotherapy followed by 4 cycles XELOX and a delayed TME, concurrent capecitabine-based long-term radiotherapy followed by a Regular TME and 6 Cycles XELOX
Keywords
High Risk Rectal Cancer, Total neoadjuvant chemoradiotherapy, Lengthening interval between radiotherapy and surgery
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • concurrent capecitabine-based long-term radiotherapy followed by 4 cycles XELOX and a delayed TMEDrug

    concurrent capecitabine-based long-term radiotherapy: capecitabine 825mg/m2,bid,d1-5, q week with Radiation treatment. Radiation treatment was given at 1·8 Gy per day, 5 days per week for 5-6 weeks, after a 45 Gy radiation dose in 25 fractions to the pelvis, a boost dose of 5·4 Gy in 3 fractions to the tumor bed or concurrent boosted.

    XELOX:

    Oxaliplatin: 130mg/m2,IV,d1; Capecitabine: 1000mg/m2,bid,d1-14; repeated every 3 weeks

    Surgery Procedure:

    Total Mesorectal Excision

  • concurrent capecitabine-based long-term radiotherapy followed by a Regular TME and 6 Cycles XELOXDrug

    concurrent capecitabine-based long-term radiotherapy: capecitabine 825mg/m2,bid,d1-5, q week with Radiation treatment. Radiation treatment was given at 1·8 Gy per day, 5 days per week for 5-6 weeks, after a 45 Gy radiation dose in 25 fractions to the pelvis, a boost dose of 5·4 Gy in 3 fractions to the tumor bed or concurrent boosted.

    XELOX:

    Oxaliplatin: 130mg/m2,IV,d1; Capecitabine: 1000mg/m2,bid,d1-14; repeated every 3 weeks

    Surgery Procedure:

    Total Mesorectal Excision

Study groups in NCT03038256
Study groupRoleWhat they receive
4 Cycles XELOX pre- TMEExperimentalexperimental group (arm B): concurrent capecitabine-based long-term radiotherapy, 4 cycles of XELOX as neoadjuvant chemotherapy and TME surgery
Receives: Drug: concurrent capecitabine-based long-term radiotherapy followed by 4 cycles XELOX and a delayed TME
6 Cycles XELOX post- TMEActive comparatorcontrol group (arm A): concurrent capecitabine-based long-term radiotherapy, TME surgery and 6 cycles of XELOX as adjuvant chemotherapy.
Receives: Drug: concurrent capecitabine-based long-term radiotherapy followed by a Regular TME and 6 Cycles XELOX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological complete response rate

    Pathological complete response (pCR) rate between control and intervention arm

    Measured: up to 30days after total mesorectal excision

Secondary outcomes (4)

  1. Disease Free Survival

    Disease Free Survival was defined as the time from the date of surgery to the date of the local recurrence, and/or distant disease, or tumor-related death.

    Measured: 3-year

  2. R0 of total mesorectal excision rate

    Overall R0 of total mesorectal excision rate between the control and intervention arm

    Measured: up to 30days after total mesorectal excision

  3. Surgery morbidity

    Surgical morbidity reported according to Clavien-Dindo classification

    Measured: 30 days and 12-months

  4. quality of surgery

    Quality of surgery determined using the mesorectal grading system

    Measured: Time of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2017 (estimated)
  2. Study start31 Jan 2018
  3. Primary completion1 Apr 2023 (estimated)
  4. Study completion1 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
244 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03038256
Sponsor's protocol ID
2016-12 EXPLORE
Acronym
EXPLORE
Status last verified
Mar 2023
First submitted
25 Jan 2017
Last updated
22 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Valentini V, van Stiphout RG, Lammering G, Gambacorta MA, Barba MC, Bebenek M, Bonnetain F, Bosset JF, Bujko K, Cionini L, Gerard JP, Rodel C, Sainato A, Sauer R, Minsky BD, Collette L, Lambin P. Nomograms for predicting local recurrence, distant metastases, and overall survival for patients with locally advanced rectal cancer on the basis of European randomized clinical trials. J Clin Oncol. 2011 Aug 10;29(23):3163-72. doi: 10.1200/JCO.2010.33.1595. Epub 2011 Jul 11.

    PubMed 21747092

  • Moran BJ. Predicting the risk and diminishing the consequences of anastomotic leakage after anterior resection for rectal cancer. Acta Chir Iugosl. 2010;57(3):47-50. doi: 10.2298/aci1003047m.

    PubMed 21066983

  • van Gijn W, Marijnen CA, Nagtegaal ID, Kranenbarg EM, Putter H, Wiggers T, Rutten HJ, Pahlman L, Glimelius B, van de Velde CJ; Dutch Colorectal Cancer Group. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer: 12-year follow-up of the multicentre, randomised controlled TME trial. Lancet Oncol. 2011 Jun;12(6):575-82. doi: 10.1016/S1470-2045(11)70097-3. Epub 2011 May 17.

    PubMed 21596621

  • Sauer R, Liersch T, Merkel S, Fietkau R, Hohenberger W, Hess C, Becker H, Raab HR, Villanueva MT, Witzigmann H, Wittekind C, Beissbarth T, Rodel C. Preoperative versus postoperative chemoradiotherapy for locally advanced rectal cancer: results of the German CAO/ARO/AIO-94 randomized phase III trial after a median follow-up of 11 years. J Clin Oncol. 2012 Jun 1;30(16):1926-33. doi: 10.1200/JCO.2011.40.1836. Epub 2012 Apr 23.

    PubMed 22529255

  • Lutz MP, Zalcberg JR, Glynne-Jones R, Ruers T, Ducreux M, Arnold D, Aust D, Brown G, Bujko K, Cunningham C, Evrard S, Folprecht G, Gerard JP, Habr-Gama A, Haustermans K, Holm T, Kuhlmann KF, Lordick F, Mentha G, Moehler M, Nagtegaal ID, Pigazzi A, Pucciarelli S, Roth A, Rutten H, Schmoll HJ, Sorbye H, Van Cutsem E, Weitz J, Otto F. Second St. Gallen European Organisation for Research and Treatment of Cancer Gastrointestinal Cancer Conference: consensus recommendations on controversial issues in the primary treatment of rectal cancer. Eur J Cancer. 2016 Aug;63:11-24. doi: 10.1016/j.ejca.2016.04.010. Epub 2016 May 30.

    PubMed 27254838

  • Chua YJ, Barbachano Y, Cunningham D, Oates JR, Brown G, Wotherspoon A, Tait D, Massey A, Tebbutt NC, Chau I. Neoadjuvant capecitabine and oxaliplatin before chemoradiotherapy and total mesorectal excision in MRI-defined poor-risk rectal cancer: a phase 2 trial. Lancet Oncol. 2010 Mar;11(3):241-8. doi: 10.1016/S1470-2045(09)70381-X. Epub 2010 Jan 25.

    PubMed 20106720

  • Glynne-Jones R, Anyamene N, Moran B, Harrison M. Neoadjuvant chemotherapy in MRI-staged high-risk rectal cancer in addition to or as an alternative to preoperative chemoradiation? Ann Oncol. 2012 Oct;23(10):2517-2526. doi: 10.1093/annonc/mds010. Epub 2012 Feb 23.

    PubMed 22367706

  • Rodel C, Graeven U, Fietkau R, Hohenberger W, Hothorn T, Arnold D, Hofheinz RD, Ghadimi M, Wolff HA, Lang-Welzenbach M, Raab HR, Wittekind C, Strobel P, Staib L, Wilhelm M, Grabenbauer GG, Hoffmanns H, Lindemann F, Schlenska-Lange A, Folprecht G, Sauer R, Liersch T; German Rectal Cancer Study Group. Oxaliplatin added to fluorouracil-based preoperative chemoradiotherapy and postoperative chemotherapy of locally advanced rectal cancer (the German CAO/ARO/AIO-04 study): final results of the multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2015 Aug;16(8):979-89. doi: 10.1016/S1470-2045(15)00159-X. Epub 2015 Jul 15.

    PubMed 26189067

  • Deng Y, Chi P, Lan P, Wang L, Chen W, Cui L, Chen D, Cao J, Wei H, Peng X, Huang Z, Cai G, Zhao R, Huang Z, Xu L, Zhou H, Wei Y, Zhang H, Zheng J, Huang Y, Zhou Z, Cai Y, Kang L, Huang M, Peng J, Ren D, Wang J. Modified FOLFOX6 With or Without Radiation Versus Fluorouracil and Leucovorin With Radiation in Neoadjuvant Treatment of Locally Advanced Rectal Cancer: Initial Results of the Chinese FOWARC Multicenter, Open-Label, Randomized Three-Arm Phase III Trial. J Clin Oncol. 2016 Sep 20;34(27):3300-7. doi: 10.1200/JCO.2016.66.6198. Epub 2016 Aug 1.

    PubMed 27480145

  • Garcia-Aguilar J, Chow OS, Smith DD, Marcet JE, Cataldo PA, Varma MG, Kumar AS, Oommen S, Coutsoftides T, Hunt SR, Stamos MJ, Ternent CA, Herzig DO, Fichera A, Polite BN, Dietz DW, Patil S, Avila K; Timing of Rectal Cancer Response to Chemoradiation Consortium. Effect of adding mFOLFOX6 after neoadjuvant chemoradiation in locally advanced rectal cancer: a multicentre, phase 2 trial. Lancet Oncol. 2015 Aug;16(8):957-66. doi: 10.1016/S1470-2045(15)00004-2. Epub 2015 Jul 14.

    PubMed 26187751

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing concurrent capecitabine-based long-term radiotherapy followed by 4 cycles XELOX and a delayed TME and concurrent capecitabine-based long-term radiotherapy followed by a Regular TME and 6 Cycles XELOX in people with Rectal Cancer and Pathological Complete Response, run by Peking University People's Hospital at 2 sites in China.

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 6 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yi Wang, MD, PHD (8610-88325813, wangyi@pkuph.edu.cn, jennifer_wy@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response rate (time frame: up to 30days after total mesorectal excision). 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 NCT03038256, which also lists 10 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 22 Mar 2023.

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