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Colorectal CancerPhase 2ERASE-TMZNCT05031975

Temozolomide and Irinotecan in Patients With MGMT Silenced Colorectal Cancer After Adjuvant Chemotherapy

A Phase 2 study testing Irinotecan and Temozolomide in people with Colorectal Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Trial summary

Surgical resection is curative for 75% of stage II and 50% of stage III colon cancer patients. The magnitude of benefit of adjuvant chemotherapy in terms of disease-free (DFS) and overall survival (OS) varies according to TNM stage and microsatellite status. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
Irinotecan and Temozolomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteItaly
Study dates
2 May 2022to 1 Jun 2024
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have provided written informed consent prior to any study specific procedures.
  • Age ≥ 18 years.
  • Histologically confirmed diagnosis of stage III or T4N0 stage II colon cancer (located 12 cm from the anal verge by endoscopy and above the peritoneal reflection at surgery) or histologically confirmed diagnosis of locally-advanced resectable rectal cancer (proximal margin located at < 12 cm from the anal verge).
  • Radical surgery for patients with colon cancer or preoperative (chemo)-radiotherapy followed by radical surgery for patients with rectal cancer.
  • Completion of at least 3 months of oxaliplatin-based (CAPOX or FOLFOX) adjuvant chemotherapy (or candidate to oxaliplatin-based adjuvant chemotherapy if post-surgery pre-screening).
  • Availability of the archival FFPE tumor tissue obtained prior to any treatment.
Show all 21Show fewer
  • Acceptance to undergo all the interventional and exploratory liquid biopsies.
  • Absent MGMT expression by IHC, MGMT promoter methylation by pyrosequencing (> 5%) and MSS by standard assessment.
  • Presence of ctDNA in the liquid biopsies collected at 2-6 weeks after the last dose of standard adjuvant chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Completion of adjuvant chemotherapy for a duration of at least three months.
  • Adequate organ function as defined below:
  • Hematological function indicated by all of the following:
  • White Blood Cell (WBC) count ≥ 2 x 109/L Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L Hemoglobin ≥ 9 g/dL (patients may have transfusions and/or growth factors to attain adequate Hb).
  • Liver function indicated by all of the following: Total bilirubin < 1.5 x upper limit of normal (ULN) Aspartate transaminase (AST) and alanine aminotransferase (ALT) < 3 x ULN Alkaline phosphatase (ALP) < 2 x ULN.
  • Renal function indicated by all of the following: Serum creatinine < 1.5 x ULN or calculated creatinine clearance > 40 ml/min.
  • Coagulation indicated by all of the following: INR ≤ 1.5 and aPTT ≤ 1.5 x ULN within 7 days prior to the start of study treatment for patients not receiving anti-coagulation. a. NOTE: The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to the medical standard of the enrolling institution) and the patient has been on a stable dose of anticoagulants for at least two weeks prior to the start of study treatment.
  • Carcinoembryonic antigen (CEA) level ≤ 10 ng/ml.
  • No evidence of distant metastases or loco-regional disease by computed tomography scan or magnetic resonance imaging.
  • Male subjects with female partners of childbearing potential must be willing to use adequate contraception as approved by the investigator (barrier contraceptive measure or oral contraception).
  • Women of childbearing potential must have a negative blood pregnancy test at the baseline visit and must be willing to use adequate contraception as approved by the investigator (barrier contraceptive measure or oral contraception). For this trial, women of childbearing potential are defined as all women after puberty, unless they are postmenopausal for at least 12 months, are surgically sterile, or are sexually inactive.

Who cannot join

  • History of another neoplastic disease, unless in remission for ≥ 5 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
  • Had an incomplete diagnostic colonoscopy and/or polyps removal.
  • Microscopic or macroscopic evidence of residual tumor (R1 or R2 resections). Patients should never have had any evidence of metastatic disease (including presence of tumor cells in the peritoneal lavage).
  • Current or recent treatment with another investigational drug or participation in another investigational study.
  • Inability to swallow pills.
  • Active infection requiring intravenous antibiotics at the start of study treatment.
Show all 13Show fewer
  • Evidence of any other disease, neurologic or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of any of the study medications, puts the patient at higher risk for treatment-related complications or may affect the interpretation of study results.
  • Patient unable to comply with the study protocol owing to psychological, social or geographical reasons.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
  • Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Sexually active males and females (of childbearing potential) unwilling to practice contraception (barrier contraceptive measure or oral contraception) during the study and until 6 months after the last trial treatment.
  • Clinically significant (i.e. active) cardiovascular disease, for example cerebrovascular accidents ≤ 6 months prior to start of study treatment, myocardial infarction ≤ 6 months prior to study enrolment, unstable angina, New York Heart Association (NYHA) Functional Classification Grade II or greater congestive heart failure, or serious cardiac arrhythmia uncontrolled by medication or potentially interfering with protocol treatment.
  • Known presence of one of the following UGT1A1 1(TA)6/UGT1A1 36(TA)5; UGT1A1 28(TA)7/UGT1A1 37(TA)8 (homozygous genotype).
  • Known presence of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption

Trial locations and contacts

1 site in 1 country.

Filippo Pietrantonio, MD contact

+390223903807

filippo.pietrantonio@istitutotumori.mi.it

Federica Morano, MD contact

+390223903842

federica.morano@istitutotumori.mi.it

Italy1 site, 1 recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, MI, 20133

    Filippo Pietrantonio, MD, +390223903695, filippo.pietrantonio@istitutotumori.mi.it

    Recruiting

Other trials in Italy

About this study

Official title: Temozolomide and Irinotecan Consolidation in Patients With MGMT Silenced, Microsatellite Stable Colorectal Cancer With Persistence of Minimal Residual Disease in Liquid Biopsy After Standard Adjuvant Chemotherapy: the ERASE-TMZ Study

Surgical resection is curative for 75% of stage II and 50% of stage III colon cancer patients. The magnitude of benefit of adjuvant chemotherapy in terms of disease-free (DFS) and overall survival (OS) varies according to TNM stage and microsatellite status. Standard adjuvant chemotherapy includes fluoropyrimidine and oxaliplatin regimens for up to six months.

Circulating tumor DNA (ctDNA) detected after surgical resection reflects the presence of micrometastatic disease and pivotal observational studies addressed the prognostic value of ctDNA in the post-surgical setting. Adjuvant chemotherapy can promote the clearance of ctDNA, and ctDNA clearance after adjuvant chemotherapy is prognostic for better DFS in patients with stage III resected cancers and post-operative positive ctDNA.

Read more

ctDNA may be investigated as a potential real-time surrogate biomarker of the efficacy of adjuvant therapy, but suggest that patients with ctDNA persistence after standard chemotherapy might be "molecularly metastatic" and may benefit from additional "consolidation" non-cross resistant strategies aimed at clearing micrometastatic disease.

Temozolomide has modest but non-negligible activity (about 10%) in chemo-refractory patients with MGMT methylated mCRC. The response rate to temozolomide-based therapy in pretreated patients is increased to up to 20% when restricting the focus on those with MGMT IHC-negative/MGMT methylated and MSS cancers Significant activity (ORR 26%) and favorable safety profile were reported by the combination of temozolomide and irinotecan (TEMIRI regimen) in patients with pretreated MGMT methylated/MSS mCRC, thus suggesting that the two agents may have synergist activity in line with preclinical data.

Based on all these considerations, there is a strong rationale for investigating TEMIRI regimen as consolidation non-cross resistant therapy in a liquid-biopsy driven interventional trial.

Eligible patients with MGMT-silenced, MSS, radically resected CRC and detectable ctDNA after standard chemotherapy will be enrolled and will receive 6-month post-adjuvant/consolidation TEMIRI (given for up to 6 monthly cycles).

Read the detailed description

Surgical resection is curative for 75% of stage II and 50% of stage III colon cancer patients. The magnitude of benefit of adjuvant chemotherapy in terms of disease-free (DFS) and overall survival (OS) varies according to TNM stage and microsatellite status. Specifically, in patients with stage II microsatellite stable (MSS) tumors and high risk clinical features (i.e. pT4, lymphovascular invasion, perineural invasion, bowel obstruction, positive surgical margins and inadequately sampled lymph nodes) adjuvant therapy with fluoropyrimidines conditioned a modest but significant DFS benefit, while oxaliplatin-based therapy may be offered to patients with poor prognosis such as those with pT4 disease. In patients with stage III disease adjuvant therapy with oxaliplatin and fluoropyrimidine combinations significantly improved DFS and OS in phase 3 randomized trials. However, oxaliplatin is burdened by dose-cumulative and potentially long-lasting neurotoxicity. Therefore, three-month duration of oxaliplatin-based chemotherapy was compared to six-month in six randomized trials including patients with resected stage (II)/III colon cancer. In the pooled analysis of such trials (IDEA Collaboration), the non-inferiority for DFS of three months adjuvant oxaliplatin-based chemotherapy was not formally demonstrated. However, absolute DFS loss with 3- month therapy was clearly unsignificant from a clinical point-of-view and 3-month duration of oxaliplatin-based adjuvant chemotherapy is now recommended in patients with low risk disease (pT3N1) and particularly when adopting a capecitabine-based regimen (CAPOX).

Circulating tumor DNA (ctDNA) detected after surgical resection reflects the presence of micrometastatic disease and pivotal observational studies addressed the prognostic value of ctDNA in the post-surgical setting. Detectable ctDNA after surgery is prognostic for DFS in patients with resected colon cancer with high specificity in predicting recurrence (-100%), reinforcing its promising role for guiding trials on post-surgical intensification strategies, but ctDNA is also endowed with suboptimal sensitivity (70%), thus limiting its potential usefulness to guide the complete omission of adjuvant chemotherapy. Regarding the impact of adjuvant chemotherapy on micrometastatic disease, adjuvant chemotherapy was able to clear ctDNA in individual patients with resected stage II tumors. Moreover, ctDNA clearance after adjuvant chemotherapy was prognostic for better DFS in patients with stage III resected cancers and post-operative positive ctDNA. Collectively, these data highlight that ctDNA may be investigated as a potential real-time surrogate biomarker of the efficacy of adjuvant therapy, but suggest that patients with ctDNA persistence after standard chemotherapy might be "molecularly metastatic" and may benefit from additional "consolidation" non-cross resistant strategies aimed at clearing micrometastatic disease.

Temozolomide displayed limited activity (overall response rate [ORR] 9%) in patients with heavily pretreated metastatic colorectal cancer (mCRC) with MGMT promoter methylation assessed by means of a qualitative assay - methylation-specific PCR. However, even if MGMT promoter methylation is found in up to 40% of patients with colorectal cancer, in-silico analyses and translational analyses showed that only a subset of these tumors (- 10% of all comers) display lack of MGMT expression and negative MGMT IHC staining. In keeping with findings, correlative studies of phase 2 trials showed that MGMT immunohistochemical negativity and higher MGMT methylation % by quantitative assays are associated with temozolomide activity. Finally, proficiency of the mismatch repair is needed for alkylators activity. Therefore, temozolomide might be considered a tailored chemotherapy in patients with MGMT silenced tumors (i.e. those with MGMT negative expression and MGMT promoter methylation) and microsatellite stable (MSS) tumors. Significant activity (ORR 26%) and favorable safety profile were reported by the combination of temozolomide and irinotecan (TEMIRI regimen) in patients with pretreated MGMT methylated/MSS mCRC, thus suggesting that the two agents may have synergist activity in line with preclinical data.

Moving from this rationale we designed a phase 2 proof-of-concept trial aimed at evaluating the activity in terms of ctDNA clearance or "seroreversion" after TEMIRI regimen as a post-adjuvant strategy in patients with MGMT silenced, MSS colorectal cancer (CRC) with positive ctDNA after oxaliplatin-based adjuvant standard chemotherapy.

Eligible patients with MGMT-silenced, MSS, radically resected CRC and detectable ctDNA after standard chemotherapy will be enrolled and will receive 6-month post-adjuvant/consolidation TEMIRI (given for up to 6 monthly cycles).

Keywords
Temozolomide, MGMT, microsatellite stable, ctDNA, TEMIRI, Stage II, Stage III, post-adjuvant
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • IrinotecanDrug

    Irinotecan 100 mg/smq intravenous infusion every 14 days

  • TemozolomideDrug

    Oral temozolomide 150 mg/sqm over days 1-5 every 28 days.

Study groups in NCT05031975
Study groupRoleWhat they receive
TEMIRIExperimentalIrinotecan intravenous infusion (IV) given every 14 days in combination with oral (PO) temozolomide over days 1-5 every 28 days. The treatment will consist of six 28-days cycles of TEMIRI.
Receives: Drug: Irinotecan; Drug: Temozolomide

What is being measured

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

  1. To assess the activity in terms of seroreversion of TEMIRI consolidation regimen administered to patients with high-risk stage II (pT4) or III MSS, MGMT silenced CRC and positive post-adjuvant ctDNA after standard oxaliplatin-based adjuvant chemotherapy.

    The activity of TEMIRI will be measured as the rate of patients with post-treatment seroreversion and disease-free at 2 years

    Measured: 2 years from randomization

Secondary outcomes (6)

  1. Disease-free survival (DFS) of patients treated with TEMIRI as consolidation regimen

    DFS is defined as the time from randomization to recurrence of tumor or death due to any cause, whichever occurs first. DFS will be censored on the date of the last evaluable on study tumour assessment documenting absence of disease relapse for patients who are alive and disease-free at the time of the analysis. Alive patients having no tumour assessments after baseline will have time to event censored on the data of enrolment

    Measured: 36 months

  2. Overall survival (OS) of patients treated with TEMIRI as consolidation regimen

    OS is defined as the time from enrolment to the date of death due to any cause. For patients still alive at the time of analysis, the OS time will be censored on the last date the patients were known to be alive.

    Measured: 36 months

  3. Safety profile of TEMIRI consolidation regimen

    Safety will be assessed by monitoring the frequency of adverse events

    Measured: 36 months

  4. Quality of life as assessed using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

    EORTC QLQ-C30 administered every 12 weeks during treatment and at the date of first documented progression, assessed up to 24 months from enrollment

    Measured: Assessed up to 24 months from enrollment

  5. Quality of life as assessed using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer 29 (EORTC QLQ-CR29)

    EORTC QLQ-CR29 administered every 12 weeks during treatment and at the date of first documented progression, assessed up to 24 months from enrollment

    Measured: Assessed up to 24 months from enrollment

  6. Quality of life as assessed using the Euro Quality of Life 5 Dimensions Questionnaire (EQ-5D-5L)

    EQ-5D-5L administered every 12 weeks during treatment and at the date of first documented progression, assessed up to 24 months from enrollment

    Measured: Assessed up to 24 months from enrollment

Timeline

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

  1. First posted2 Sep 2021
  2. Study start2 May 2022
  3. Primary completion1 Jun 2024 (estimated)
  4. Study completion1 Jun 2024 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05031975
Sponsor's protocol ID
INT 03/21
Acronym
ERASE-TMZ
Status last verified
Aug 2022
First submitted
24 Aug 2021
Last updated
2 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ribic CM, Sargent DJ, Moore MJ, Thibodeau SN, French AJ, Goldberg RM, Hamilton SR, Laurent-Puig P, Gryfe R, Shepherd LE, Tu D, Redston M, Gallinger S. Tumor microsatellite-instability status as a predictor of benefit from fluorouracil-based adjuvant chemotherapy for colon cancer. N Engl J Med. 2003 Jul 17;349(3):247-57. doi: 10.1056/NEJMoa022289.

    PubMed 12867608

  • Quasar Collaborative Group; Gray R, Barnwell J, McConkey C, Hills RK, Williams NS, Kerr DJ. Adjuvant chemotherapy versus observation in patients with colorectal cancer: a randomised study. Lancet. 2007 Dec 15;370(9604):2020-9. doi: 10.1016/S0140-6736(07)61866-2.

    PubMed 18083404

  • Bockelman C, Engelmann BE, Kaprio T, Hansen TF, Glimelius B. Risk of recurrence in patients with colon cancer stage II and III: a systematic review and meta-analysis of recent literature. Acta Oncol. 2015 Jan;54(1):5-16. doi: 10.3109/0284186X.2014.975839. Epub 2014 Nov 28.

    PubMed 25430983

  • Andre T, de Gramont A, Vernerey D, Chibaudel B, Bonnetain F, Tijeras-Raballand A, Scriva A, Hickish T, Tabernero J, Van Laethem JL, Banzi M, Maartense E, Shmueli E, Carlsson GU, Scheithauer W, Papamichael D, Moehler M, Landolfi S, Demetter P, Colote S, Tournigand C, Louvet C, Duval A, Flejou JF, de Gramont A. Adjuvant Fluorouracil, Leucovorin, and Oxaliplatin in Stage II to III Colon Cancer: Updated 10-Year Survival and Outcomes According to BRAF Mutation and Mismatch Repair Status of the MOSAIC Study. J Clin Oncol. 2015 Dec 10;33(35):4176-87. doi: 10.1200/JCO.2015.63.4238. Epub 2015 Nov 2.

    PubMed 26527776

  • Andre T, Boni C, Mounedji-Boudiaf L, Navarro M, Tabernero J, Hickish T, Topham C, Zaninelli M, Clingan P, Bridgewater J, Tabah-Fisch I, de Gramont A; Multicenter International Study of Oxaliplatin/5-Fluorouracil/Leucovorin in the Adjuvant Treatment of Colon Cancer (MOSAIC) Investigators. Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med. 2004 Jun 3;350(23):2343-51. doi: 10.1056/NEJMoa032709.

    PubMed 15175436

  • Andre T, Boni C, Navarro M, Tabernero J, Hickish T, Topham C, Bonetti A, Clingan P, Bridgewater J, Rivera F, de Gramont A. Improved overall survival with oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial. J Clin Oncol. 2009 Jul 1;27(19):3109-16. doi: 10.1200/JCO.2008.20.6771. Epub 2009 May 18.

    PubMed 19451431

  • Yothers G, O'Connell MJ, Allegra CJ, Kuebler JP, Colangelo LH, Petrelli NJ, Wolmark N. Oxaliplatin as adjuvant therapy for colon cancer: updated results of NSABP C-07 trial, including survival and subset analyses. J Clin Oncol. 2011 Oct 1;29(28):3768-74. doi: 10.1200/JCO.2011.36.4539. Epub 2011 Aug 22.

    PubMed 21859995

  • Kuebler JP, Wieand HS, O'Connell MJ, Smith RE, Colangelo LH, Yothers G, Petrelli NJ, Findlay MP, Seay TE, Atkins JN, Zapas JL, Goodwin JW, Fehrenbacher L, Ramanathan RK, Conley BA, Flynn PJ, Soori G, Colman LK, Levine EA, Lanier KS, Wolmark N. Oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: results from NSABP C-07. J Clin Oncol. 2007 Jun 1;25(16):2198-204. doi: 10.1200/JCO.2006.08.2974. Epub 2007 Apr 30.

    PubMed 17470851

  • Schmoll HJ, Tabernero J, Maroun J, de Braud F, Price T, Van Cutsem E, Hill M, Hoersch S, Rittweger K, Haller DG. Capecitabine Plus Oxaliplatin Compared With Fluorouracil/Folinic Acid As Adjuvant Therapy for Stage III Colon Cancer: Final Results of the NO16968 Randomized Controlled Phase III Trial. J Clin Oncol. 2015 Nov 10;33(32):3733-40. doi: 10.1200/JCO.2015.60.9107. Epub 2015 Aug 31.

    PubMed 26324362

  • Haller DG, Tabernero J, Maroun J, de Braud F, Price T, Van Cutsem E, Hill M, Gilberg F, Rittweger K, Schmoll HJ. Capecitabine plus oxaliplatin compared with fluorouracil and folinic acid as adjuvant therapy for stage III colon cancer. J Clin Oncol. 2011 Apr 10;29(11):1465-71. doi: 10.1200/JCO.2010.33.6297. Epub 2011 Mar 7.

    PubMed 21383294

  • Sobrero A, Lonardi S, Rosati G, Di Bartolomeo M, Ronzoni M, Pella N, Scartozzi M, Banzi M, Zampino MG, Pasini F, Marchetti P, Cantore M, Zaniboni A, Rimassa L, Ciuffreda L, Ferrari D, Zagonel V, Maiello E, Barni S, Rulli E, Labianca R; TOSCA Investigators. FOLFOX or CAPOX in Stage II to III Colon Cancer: Efficacy Results of the Italian Three or Six Colon Adjuvant Trial. J Clin Oncol. 2018 May 20;36(15):1478-1485. doi: 10.1200/JCO.2017.76.2187. Epub 2018 Apr 5.

    PubMed 29620994

  • Iveson TJ, Kerr RS, Saunders MP, Cassidy J, Hollander NH, Tabernero J, Haydon A, Glimelius B, Harkin A, Allan K, McQueen J, Scudder C, Boyd KA, Briggs A, Waterston A, Medley L, Wilson C, Ellis R, Essapen S, Dhadda AS, Harrison M, Falk S, Raouf S, Rees C, Olesen RK, Propper D, Bridgewater J, Azzabi A, Farrugia D, Webb A, Cunningham D, Hickish T, Weaver A, Gollins S, Wasan HS, Paul J. 3 versus 6 months of adjuvant oxaliplatin-fluoropyrimidine combination therapy for colorectal cancer (SCOT): an international, randomised, phase 3, non-inferiority trial. Lancet Oncol. 2018 Apr;19(4):562-578. doi: 10.1016/S1470-2045(18)30093-7.

    PubMed 29611518

  • Andre T, Vernerey D, Mineur L, Bennouna J, Desrame J, Faroux R, Fratte S, Hug de Larauze M, Paget-Bailly S, Chibaudel B, Bez J, Dauba J, Louvet C, Lepere C, Dupuis O, Becouarn Y, Mabro M, Egreteau J, Bouche O, Deplanque G, Ychou M, Galais MP, Ghiringhelli F, Dourthe LM, Bachet JB, Khalil A, Bonnetain F, de Gramont A, Taieb J; for PRODIGE investigators, GERCOR, Federation Francaise de Cancerologie Digestive, and UNICANCER. Three Versus 6 Months of Oxaliplatin-Based Adjuvant Chemotherapy for Patients With Stage III Colon Cancer: Disease-Free Survival Results From a Randomized, Open-Label, International Duration Evaluation of Adjuvant (IDEA) France, Phase III Trial. J Clin Oncol. 2018 May 20;36(15):1469-1477. doi: 10.1200/JCO.2017.76.0355. Epub 2018 Apr 5.

    PubMed 29620995

  • Meyerhardt JA, Shi Q, Fuchs CS, Meyer J, Niedzwiecki D, Zemla T, Kumthekar P, Guthrie KA, Couture F, Kuebler P, Bendell JC, Kumar P, Lewis D, Tan B, Bertagnolli M, Grothey A, Hochster HS, Goldberg RM, Venook A, Blanke C, O'Reilly EM, Shields AF. Effect of Celecoxib vs Placebo Added to Standard Adjuvant Therapy on Disease-Free Survival Among Patients With Stage III Colon Cancer: The CALGB/SWOG 80702 (Alliance) Randomized Clinical Trial. JAMA. 2021 Apr 6;325(13):1277-1286. doi: 10.1001/jama.2021.2454.

    PubMed 33821899

  • Souglakos J, Boukovinas I, Kakolyris S, Xynogalos S, Ziras N, Athanasiadis A, Androulakis N, Christopoulou A, Vaslamatzis M, Ardavanis A, Emmanouilides C, Bompolaki I, Kourousis C, Makrantonakis P, Christofyllakis C, Athanasiadis E, Kentepozidis N, Karampeazis A, Katopodi U, Anagnosopoulos A, Papadopoulos G, Prinarakis E, Kalisperi A, Mavroudis D, Georgoulias V. Three- versus six-month adjuvant FOLFOX or CAPOX for high-risk stage II and stage III colon cancer patients: the efficacy results of Hellenic Oncology Research Group (HORG) participation to the International Duration Evaluation of Adjuvant Chemotherapy (IDEA) project. Ann Oncol. 2019 Aug 1;30(8):1304-1310. doi: 10.1093/annonc/mdz193.

    PubMed 31228203

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Irinotecan and Temozolomide in people with Colorectal Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.

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 21 inclusion and 13 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 2 Sep 2022. 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 Italy. 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 Filippo Pietrantonio, MD (+390223903807, filippo.pietrantonio@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the activity in terms of seroreversion of TEMIRI consolidation regimen administered to patients with high-risk stage II (pT4) or III MSS, MGMT silenced CRC and positive post-adjuvant ctDNA after standard oxaliplatin-based adjuvant chemotherapy. (time frame: 2 years from 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 NCT05031975, which also lists 45 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 2 Sep 2022.

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