Rectal CancerPhase 3NCT06246344

Adaptive Boost Radiotherapy to Primary Lesions and Positive Nodes in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer

A Phase 3 study testing Online Adaptive Radiotherapy With Sequential Boost, Conventional Non-Adaptive IMRT and Capecitabine in people with Rectal Cancer, run by Shandong Cancer Hospital and Institute at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Rectal Cancer
What is being tested?: Online Adaptive Radiotherapy With Sequential Boost, Conventional Non-Adaptive IMRT and Capecitabine
Type of treatment: Pill or oral medicine, Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 128 participants
Where: 1 siteChina
Study dates: 1 Dec 2023to 1 Dec 2030
Phase: Phase 3
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 years or older.
ECOG performance status of 0 or 1.
Histologically confirmed rectal adenocarcinoma.
Primary tumor located within 10 cm of the anal verge by pelvic MRI and/or rigid sigmoidoscopy.
Clinically involved regional lymph nodes (cN1-2) according to the AJCC 8th edition.
At least one additional high-risk feature: cT4 disease, cN2 disease, extramural vascular invasion, mesorectal fascia involvement, lateral pelvic lymph-node involvement, tumor deposits, or low rectal cancer (≤5 cm from the anal verge).

Show all 10Show fewer

Baseline locoregional staging with contrast-enhanced pelvic MRI and chest/abdominal imaging excluding distant metastases.
Treatment-naïve with respect to systemic therapy and pelvic radiotherapy for the index rectal cancer and suitable for total mesorectal excision.
Adequate organ function and no medical contraindication to chemoradiotherapy.
Written informed consent before study-specific procedures.

Who cannot join

Prior pelvic radiotherapy.
Prior rectal surgery for the index cancer, including local excision or transanal procedures.
Radiologically or pathologically confirmed distant metastasis.
Locally recurrent rectal cancer.
Active inflammatory bowel disease.
History of another primary malignancy within the preceding 5 years, except adequately treated non-melanoma skin cancer or carcinoma in situ.

Show all 9Show fewer

Pregnancy or lactation.
Severe or uncontrolled medical condition contraindicating chemoradiotherapy or surgery.
Clinically significant hypersensitivity to protocol systemic therapy that precludes treatment.

Trial locations and contacts

1 site in 1 country.

China1 site

Department of Radiation Oncology, Shandong Cancer Hospital and Institute
Jinan, Shandong, 0531

Other trials in China

About this study

Official title: Online Adaptive Radiotherapy With a Boost to the Primary Tumor and Clinically Involved Lymph Nodes in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer: A Prospective, Randomized Controlled Trial

This prospective, single-center, randomized controlled trial evaluates whether online adaptive radiotherapy (ART) with a sequential boost to both the primary rectal tumor and clinically involved lymph nodes improves pathologic complete response in patients with high-risk, node-positive locally advanced rectal cancer. Participants were randomly assigned 1:1 to online ART with a sequential boost or conventional non-adaptive intensity-modulated radiotherapy (IMRT). Both groups received concurrent capecitabine during long-course chemoradiotherapy, followed by 3-4 cycles of CAPEOX consolidation chemotherapy and planned total mesorectal excision. The planned sample size was 128 participants. Enrollment was discontinued after an interim review after 76 participants had been randomized; long-term follow-up of enrolled participants is ongoing.

Read the detailed description

The trial was originally designed to evaluate adaptive dose escalation to the primary rectal tumor and clinically involved lymph nodes during neoadjuvant treatment for locally advanced rectal cancer. During trial conduct, the protocol was amended to reflect the treatment strategy implemented in the enrolled cohort. Enrollment was operationally consolidated at the lead center. Online ART was delivered using either MR-guided or CBCT-guided workflows. In the experimental arm, a sequential boost of 9 Gy in 3 fractions or 10 Gy in 2 fractions was delivered to the primary tumor and clinically involved lymph nodes, followed by online ART to 50 Gy in 25 fractions to the pelvic clinical target volume. The control arm received conventional non-adaptive IMRT to 50 Gy in 25 fractions without dose escalation. Both groups received concurrent capecitabine and 3-4 cycles of CAPEOX consolidation chemotherapy.

The planned enrollment was 128 participants. During trial conduct, an interim review was undertaken after 76 participants had been randomized. The interim analysis had not been specified in the original protocol and no formal group-sequential efficacy or futility boundary had been prespecified. Enrollment was subsequently discontinued, while protocol-defined follow-up of enrolled participants continues.

Conditions: Rectal Cancer
Being tested: Online Adaptive Radiotherapy With Sequential Boost, Conventional Non-Adaptive IMRT, Capecitabine, CAPEOX, Total Mesorectal Excision
Keywords: neoadjuvant, rectal cancer, chemoradiotherapy
Medical subject headings: Rectal Neoplasms

What participants receive

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

Online Adaptive Radiotherapy With Sequential BoostRadiation
MR- or CBCT-guided online adaptive radiotherapy with daily imaging, target and organ-at-risk review, and plan reoptimization. A sequential boost of 9 Gy in 3 fractions or 10 Gy in 2 fractions is delivered to GTVp and GTVn, followed by 50 Gy in 25 fractions to the pelvic CTV.
Conventional Non-Adaptive IMRTRadiation
Conventional non-adaptive intensity-modulated radiotherapy to the pelvic CTV at 50 Gy in 25 fractions without dose escalation.
CapecitabineDrug
Capecitabine 825 mg/m² orally twice daily during long-course chemoradiotherapy.
CAPEOXDrug
Consolidation chemotherapy consisting of capecitabine 1000 mg/m² orally twice daily on days 1-14 plus oxaliplatin 130 mg/m² intravenously on day 1 every 3 weeks for 3-4 cycles after chemoradiotherapy.
Total Mesorectal ExcisionProcedure or surgery
Total mesorectal excision planned after completion of neoadjuvant treatment according to standard surgical principles.

Study groups in NCT06246344
Study group	Role	What they receive
Online ART With Sequential Boost	Experimental	Participants received online adaptive radiotherapy using MR- or CBCT-guided workflows. A sequential boost of either 9 Gy in 3 fractions or 10 Gy in 2 fractions was delivered to the primary rectal tumor (GTVp) and clinically involved lymph nodes (GTVn), followed by continued online ART to 50 Gy in 25 fractions to the pelvic clinical target volume. Concurrent capecitabine was administered during radiotherapy, followed by 3-4 cycles of CAPEOX consolidation chemotherapy and planned total mesorectal excision. Receives: Radiation: Online Adaptive Radiotherapy With Sequential Boost; Drug: Capecitabine; Drug: CAPEOX; Procedure: Total Mesorectal Excision
Conventional Non-Adaptive IMRT	Active comparator	Participants received conventional non-adaptive intensity-modulated radiotherapy to the pelvic clinical target volume at 50 Gy in 25 fractions without dose escalation. Concurrent capecitabine was administered during radiotherapy, followed by 3-4 cycles of CAPEOX consolidation chemotherapy and planned total mesorectal excision. Receives: Radiation: Conventional Non-Adaptive IMRT; Drug: Capecitabine; Drug: CAPEOX; Procedure: Total Mesorectal Excision

What is being measured

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

pCR
Proportion of participants achieving ypT0N0, defined as absence of viable tumor cells in the resected primary tumor and regional lymph nodes after neoadjuvant treatment.
Measured: At total mesorectal excision after completion of neoadjuvant therapy, up to approximately 6 months after randomization

Secondary outcomes (9)

Surgical Difficulty
urgical difficulty is assessed using a predefined 8-item composite score incorporating operative time, conversion to laparotomy, non-routine transanal assistance, visible pelvic fibrosis, bowel edema, intraoperative blood loss, postoperative hospital stay, and postoperative complications. The total score ranges from 0 to 12; a score ≥3 defines difficult surgery.
Measured: Time Frame: Perioperative through 30 days after surgery
Clinical Complete Response (cCR) Rate
Proportion of participants meeting the protocol-defined criteria for clinical complete response at restaging, based on pelvic MRI, endoscopy, and digital rectal examination, with biopsy when performed. Criteria include no residual tumor or only residual fibrosis on MRI, no suspicious residual lymph nodes, no residual tumor on endoscopy or only a small scar/ulcer, and no palpable residual tumor.
Measured: At preoperative restaging after completion of neoadjuvant therapy, before planned surgery
3-year overal survival rate
The proportion of patients from the commencement of self-diagnosis to the time of death for any reason within 3 years
Measured: 3 years
5-year overal survival rate
The proportion of patients from the commencement of self-diagnosis to the time of death for any reason within 5 years
Measured: 5 years
3-year disease free survival rate
The proportion of patients from the initiation of surgery to tumor recurrence or death within 3 years
Measured: 3 years
5-year disease free suvival rate
The proportion of patients from the initiation of surgery to tumor recurrence or death within 5 years
Measured: 5 years
Treatment-related adverse events
Number and proportion of participants experiencing treatment-related adverse events, graded according to CTCAE version 5.0 and protocol-specified radiation morbidity criteria.
Measured: 1 year
Perioperative complications
Incidence of perioperative complications after TME, including wound/incision complications, bleeding, infection, and procedure-specific complications
Measured: From surgery through 30 days after surgery
Perineal wound healing after APR
Perineal wound-healing outcomes and wound complications among participants undergoing abdominoperineal resection.
Measured: Through 6 months after surgery

Timeline

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

1 Dec 20231 Dec 2030

First posted7 Feb 2024
Study start1 Dec 2023
Primary completion1 Dec 2025
Study completion1 Dec 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Rectal CancerStudies of the same condition, open and under way.
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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 128 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06246344
Sponsor's protocol ID: SDZLEC2023-390-02
Status last verified: Sep 2026
First submitted: 28 Jan 2024
Last updated: 15 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12.
PubMed 33433946
Gollins S, Sebag-Montefiore D. Neoadjuvant Treatment Strategies for Locally Advanced Rectal Cancer. Clin Oncol (R Coll Radiol). 2016 Feb;28(2):146-151. doi: 10.1016/j.clon.2015.11.003. Epub 2015 Nov 29.
PubMed 26645661
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
Lefevre JH, Mineur L, Kotti S, Rullier E, Rouanet P, de Chaisemartin C, Meunier B, Mehrdad J, Cotte E, Desrame J, Karoui M, Benoist S, Kirzin S, Berger A, Panis Y, Piessen G, Saudemont A, Prudhomme M, Peschaud F, Dubois A, Loriau J, Tuech JJ, Meurette G, Lupinacci R, Goasgen N, Parc Y, Simon T, Tiret E. Effect of Interval (7 or 11 weeks) Between Neoadjuvant Radiochemotherapy and Surgery on Complete Pathologic Response in Rectal Cancer: A Multicenter, Randomized, Controlled Trial (GRECCAR-6). J Clin Oncol. 2016 Nov 1;34(31):3773-3780. doi: 10.1200/JCO.2016.67.6049.
PubMed 27432930
Fokas E, Schlenska-Lange A, Polat B, Klautke G, Grabenbauer GG, Fietkau R, Kuhnt T, Staib L, Brunner T, Grosu AL, Kirste S, Jacobasch L, Allgauer M, Flentje M, Germer CT, Grutzmann R, Hildebrandt G, Schwarzbach M, Bechstein WO, Sulberg H, Friede T, Gaedcke J, Ghadimi M, Hofheinz RD, Rodel C; German Rectal Cancer Study Group. Chemoradiotherapy Plus Induction or Consolidation Chemotherapy as Total Neoadjuvant Therapy for Patients With Locally Advanced Rectal Cancer: Long-term Results of the CAO/ARO/AIO-12 Randomized Clinical Trial. JAMA Oncol. 2022 Jan 1;8(1):e215445. doi: 10.1001/jamaoncol.2021.5445. Epub 2022 Jan 20.
PubMed 34792531
Fernandez-Martos C, Garcia-Albeniz X, Pericay C, Maurel J, Aparicio J, Montagut C, Safont MJ, Salud A, Vera R, Massuti B, Escudero P, Alonso V, Bosch C, Martin M, Minsky BD. Chemoradiation, surgery and adjuvant chemotherapy versus induction chemotherapy followed by chemoradiation and surgery: long-term results of the Spanish GCR-3 phase II randomized trialdagger. Ann Oncol. 2015 Aug;26(8):1722-8. doi: 10.1093/annonc/mdv223. Epub 2015 May 8.
PubMed 25957330
Camma C, Giunta M, Fiorica F, Pagliaro L, Craxi A, Cottone M. Preoperative radiotherapy for resectable rectal cancer: A meta-analysis. JAMA. 2000 Aug 23-30;284(8):1008-15. doi: 10.1001/jama.284.8.1008.
PubMed 10944647
Ngan SY, Burmeister B, Fisher RJ, Solomon M, Goldstein D, Joseph D, Ackland SP, Schache D, McClure B, McLachlan SA, McKendrick J, Leong T, Hartopeanu C, Zalcberg J, Mackay J. Randomized trial of short-course radiotherapy versus long-course chemoradiation comparing rates of local recurrence in patients with T3 rectal cancer: Trans-Tasman Radiation Oncology Group trial 01.04. J Clin Oncol. 2012 Nov 1;30(31):3827-33. doi: 10.1200/JCO.2012.42.9597. Epub 2012 Sep 24.
PubMed 23008301
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
Wang H, Zhang X, Leng B, Zhu K, Jiang S, Feng R, Dou X, Shi F, Xu L, Yue J. Efficacy and safety of MR-guided adaptive simultaneous integrated boost radiotherapy to primary lesions and positive lymph nodes in the neoadjuvant treatment of locally advanced rectal cancer: a randomized controlled phase III trial. Radiat Oncol. 2024 Sep 12;19(1):118. doi: 10.1186/s13014-024-02506-6.
PubMed 39267085

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Rectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Online Adaptive Radiotherapy With a Boost to the Primary Tumor and Clinically Involved Lymph Nodes in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer: A Prospective, Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06246344
Acronym / sponsor ID: SDZLEC2023-390-02
Conditions: Rectal Cancer
Keywords: neoadjuvant, rectal cancer, chemoradiotherapy
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 128 participants (estimated)
Lead sponsor: Shandong Cancer Hospital and InstituteUniversity, hospital or other
Study start: 1 Dec 2023 (actual)
Primary completion: 1 Dec 2025 (actual)
Study completion: 1 Dec 2030 (estimated)
First posted: 7 Feb 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Online ART With Sequential Boost	Experimental	Radiation: Online Adaptive Radiotherapy With Sequential Boost, Drug: Capecitabine, Drug: CAPEOX, Procedure: Total Mesorectal ExcisionParticipants received online adaptive radiotherapy using MR- or CBCT-guided workflows. A sequential boost of either 9 Gy in 3 fractions or 10 Gy in 2 fractions was delivered to the primary rectal tumor (GTVp) and clinically involved lymph nodes (GTVn), followed by continued online ART to 50 Gy in 25 fractions to the pelvic clinical target volume. Concurrent capecitabine was administered during radiotherapy, followed by 3-4 cycles of CAPEOX consolidation chemotherapy and planned total mesorectal excision.
Conventional Non-Adaptive IMRT	Active comparator	Radiation: Conventional Non-Adaptive IMRT, Drug: Capecitabine, Drug: CAPEOX, Procedure: Total Mesorectal ExcisionParticipants received conventional non-adaptive intensity-modulated radiotherapy to the pelvic clinical target volume at 50 Gy in 25 fractions without dose escalation. Concurrent capecitabine was administered during radiotherapy, followed by 3-4 cycles of CAPEOX consolidation chemotherapy and planned total mesorectal excision.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Age 18 years or older.
ECOG performance status of 0 or 1.
Histologically confirmed rectal adenocarcinoma.
Primary tumor located within 10 cm of the anal verge by pelvic MRI and/or rigid sigmoidoscopy.
Clinically involved regional lymph nodes (cN1-2) according to the AJCC 8th edition.

Key exclusion criteria (9 listed)

Prior pelvic radiotherapy.
Prior rectal surgery for the index cancer, including local excision or transanal procedures.
Radiologically or pathologically confirmed distant metastasis.
Locally recurrent rectal cancer.
Active inflammatory bowel disease.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Online Adaptive Radiotherapy With Sequential BoostMR- or CBCT-guided online adaptive radiotherapy with daily imaging, target and organ-at-risk review, and plan reoptimization. A sequential boost of 9 Gy in 3 fractions or 10 Gy in 2 fractions is delivered to GTVp and GTVn, followed by 50 Gy in 25 fractions to the pelvic CTV.	Radiation	Online ART With Sequential Boost
Conventional Non-Adaptive IMRTConventional non-adaptive intensity-modulated radiotherapy to the pelvic CTV at 50 Gy in 25 fractions without dose escalation.	Radiation	Conventional Non-Adaptive IMRT
CapecitabineCapecitabine 825 mg/m² orally twice daily during long-course chemoradiotherapy.	Drug	Conventional Non-Adaptive IMRT, Online ART With Sequential Boost
CAPEOXConsolidation chemotherapy consisting of capecitabine 1000 mg/m² orally twice daily on days 1-14 plus oxaliplatin 130 mg/m² intravenously on day 1 every 3 weeks for 3-4 cycles after chemoradiotherapy.	Drug	Conventional Non-Adaptive IMRT, Online ART With Sequential Boost
Total Mesorectal ExcisionTotal mesorectal excision planned after completion of neoadjuvant treatment according to standard surgical principles.	Procedure or surgery	Conventional Non-Adaptive IMRT, Online ART With Sequential Boost

Primary outcome

pCR
Time frame: At total mesorectal excision after completion of neoadjuvant therapy, up to approximately 6 months after randomization
Proportion of participants achieving ypT0N0, defined as absence of viable tumor cells in the resected primary tumor and regional lymph nodes after neoadjuvant treatment.

9 secondary outcomes

Surgical Difficulty
Time frame: Time Frame: Perioperative through 30 days after surgery
Clinical Complete Response (cCR) Rate
Time frame: At preoperative restaging after completion of neoadjuvant therapy, before planned surgery
3-year overal survival rate
Time frame: 3 years
5-year overal survival rate
Time frame: 5 years
3-year disease free survival rate
Time frame: 3 years
5-year disease free suvival rate
Time frame: 5 years
Treatment-related adverse events
Time frame: 1 year
Perioperative complications
Time frame: From surgery through 30 days after surgery
Perineal wound healing after APR
Time frame: Through 6 months after surgery

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 15 Sep 2026.
Results publication: PubMed 33433946Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12.
Results publication: PubMed 26645661Gollins S, Sebag-Montefiore D. Neoadjuvant Treatment Strategies for Locally Advanced Rectal Cancer. Clin Oncol (R Coll Radiol). 2016 Feb;28(2):146-151. doi: 10.1016/j.clon.2015.11.003. Epub 2015 Nov 29.
Results publication: PubMed 21596621van 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.
Results publication: PubMed 27432930Lefevre JH, Mineur L, Kotti S, Rullier E, Rouanet P, de Chaisemartin C, Meunier B, Mehrdad J, Cotte E, Desrame J, Karoui M, Benoist S, Kirzin S, Berger A, Panis Y, Piessen G, Saudemont A, Prudhomme M, Peschaud F, Dubois A, Loriau J, Tuech JJ, Meurette G, Lupinacci R, Goasgen N, Parc Y, Simon T, Tiret E. Effect of Interval (7 or 11 weeks) Between Neoadjuvant Radiochemotherapy and Surgery on Complete Pathologic Response in Rectal Cancer: A Multicenter, Randomized, Controlled Trial (GRECCAR-6). J Clin Oncol. 2016 Nov 1;34(31):3773-3780. doi: 10.1200/JCO.2016.67.6049.
Results publication: PubMed 34792531Fokas E, Schlenska-Lange A, Polat B, Klautke G, Grabenbauer GG, Fietkau R, Kuhnt T, Staib L, Brunner T, Grosu AL, Kirste S, Jacobasch L, Allgauer M, Flentje M, Germer CT, Grutzmann R, Hildebrandt G, Schwarzbach M, Bechstein WO, Sulberg H, Friede T, Gaedcke J, Ghadimi M, Hofheinz RD, Rodel C; German Rectal Cancer Study Group. Chemoradiotherapy Plus Induction or Consolidation Chemotherapy as Total Neoadjuvant Therapy for Patients With Locally Advanced Rectal Cancer: Long-term Results of the CAO/ARO/AIO-12 Randomized Clinical Trial. JAMA Oncol. 2022 Jan 1;8(1):e215445. doi: 10.1001/jamaoncol.2021.5445. Epub 2022 Jan 20.
Results publication: PubMed 25957330Fernandez-Martos C, Garcia-Albeniz X, Pericay C, Maurel J, Aparicio J, Montagut C, Safont MJ, Salud A, Vera R, Massuti B, Escudero P, Alonso V, Bosch C, Martin M, Minsky BD. Chemoradiation, surgery and adjuvant chemotherapy versus induction chemotherapy followed by chemoradiation and surgery: long-term results of the Spanish GCR-3 phase II randomized trialdagger. Ann Oncol. 2015 Aug;26(8):1722-8. doi: 10.1093/annonc/mdv223. Epub 2015 May 8.
Results publication: PubMed 10944647Camma C, Giunta M, Fiorica F, Pagliaro L, Craxi A, Cottone M. Preoperative radiotherapy for resectable rectal cancer: A meta-analysis. JAMA. 2000 Aug 23-30;284(8):1008-15. doi: 10.1001/jama.284.8.1008.
Results publication: PubMed 23008301Ngan SY, Burmeister B, Fisher RJ, Solomon M, Goldstein D, Joseph D, Ackland SP, Schache D, McClure B, McLachlan SA, McKendrick J, Leong T, Hartopeanu C, Zalcberg J, Mackay J. Randomized trial of short-course radiotherapy versus long-course chemoradiation comparing rates of local recurrence in patients with T3 rectal cancer: Trans-Tasman Radiation Oncology Group trial 01.04. J Clin Oncol. 2012 Nov 1;30(31):3827-33. doi: 10.1200/JCO.2012.42.9597. Epub 2012 Sep 24.
Results publication: PubMed 26187751Garcia-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.
Derived from this study: PubMed 39267085Wang H, Zhang X, Leng B, Zhu K, Jiang S, Feng R, Dou X, Shi F, Xu L, Yue J. Efficacy and safety of MR-guided adaptive simultaneous integrated boost radiotherapy to primary lesions and positive lymph nodes in the neoadjuvant treatment of locally advanced rectal cancer: a randomized controlled phase III trial. Radiat Oncol. 2024 Sep 12;19(1):118. doi: 10.1186/s13014-024-02506-6.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Jinbo Yue, Doctor principal investigator

Shandong Cancer Hospital and Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pCR (time frame: At total mesorectal excision after completion of neoadjuvant therapy, up to approximately 6 months after randomization). 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 NCT06246344, 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 15 Sep 2026.